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XTANDI Support Solutions®

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Overview Patient Support Provider Support

XTANDI Support Solutions

XTANDI Support Solutions* offers access and reimbursement support to help patients access XTANDI. XTANDI Support Solutions provides information regarding patient healthcare coverage, financial assistance options that may be available to help patients with financial needs, and HCP support on matters related to access and reimbursement.

Contact XTANDI Support Solutions

If you have questions or need assistance regarding access or reimbursement for XTANDI:

CALL

1-855-8XTANDI (855-898-2634), Monday–Friday, 8:00 AM–8:00 PM ET

IN PERSON

Access and Reimbursement Manager (ARM)
The HCP office has access to an ARM who can provide education on matters related to access and reimbursement. Your XTANDI Sales Representative can provide you with the ARM's contact information.

To quickly enroll your patients in XTANDI Support Solutions, visit XTANDIAccess.com

*XTANDI Support Solutions is a component of Astellas Pharma Support Solutions^SM. Terms and conditions apply.

Patient Support

HOW TO ENROLL IN XTANDI SUPPORT SOLUTIONS

XTANDI Access allows you to enroll your patients in XTANDI Support Solutions online. XTANDI Support Solutions offers access and reimbursement support to help patients overcome challenges accessing XTANDI.

For a faster and more efficient enrollment,
visit XTANDIaccess.com

Enroll Now

View and download printable enrollment forms:
Patient Authorization Form (PDF); XTANDI Support Solutions® Patient Enrollment Form (PDF)

COST AND COPAY SUPPORT

Assistance for Commercially Insured Patients

The XTANDI Patient Savings Program* is for eligible commercially insured patients taking XTANDI tablets. The Program parameters are as follows:

Patients may pay as little as $0 per prescription
Patients will be enrolled in the Program for a 12-month period
There are no income requirements
There is a maximum copay assistance limit of $7000 per calendar year^†

Eligibility restrictions, terms, and conditions apply.

Initiating enrollment on behalf of your patients

HCPs can begin the Program enrollment process on behalf of their patients by following these steps:

STEP 1:

GO to XTANDIcopayenroll.com
ENTER your patient's demographic information

STEP 2:

CONFIRM if you are the HCP or specialty pharmacy enrolling on behalf of your patient

STEP 3:

ANSWER questions to confirm your patient's eligibility, including their insurance status and place of residence

STEP 4:

ATTEST that you have shared the terms and conditions for the XTANDI Patient Savings Program with the patient. Confirm that the patient has consented to comply with such terms and conditions

STEP 5:

PRINT your patient's copay program processing information. If you are the HCP, please send this information to your patient's specialty pharmacy. If you are the specialty pharmacy, please save this information to your patient's records and process the copay program claim accordingly
INFORM your patient that they will receive a copy of their copay program details via a mailed letter and email (if provided during enrollment)

For more information about the XTANDI Patient Savings Program:

Please call us at 1-855-217-8311 for additional information or for help enrolling into the Program. We are available Monday–Friday, 8 AM–8 PM ET.

*By enrolling in the XTANDI Patient Savings Program ("Program"), the patient acknowledges that they currently meet the eligibility criteria and will comply with the following terms and conditions: The Program is for eligible patients with commercial prescription insurance coverage for XTANDI® (enzalutamide) and is good for use only with a valid prescription for the XTANDI tablet formulation. The Program is not valid for patients whose prescription claims are reimbursed, in whole or in part, by any state or federal government program, including, but not limited to, Medicaid, Medicare, Medigap, Department of Defense (DoD), Veterans Affairs (VA), TRICARE, Puerto Rico Government Insurance, or any state patient or pharmaceutical assistance program. Patients who move from commercial insurance to federal or state health insurance will no longer be eligible, and agree to notify the Program of any such change. Patients agree not to seek reimbursement from any health insurance or third party for all or any part of the benefit received by the patient through the Program. This offer is not conditioned on any past, present, or future purchase of XTANDI. This offer is not transferrable and cannot be combined with any other offer, free trial, prescription savings card, or discount. The full value of the Program benefits is intended to pass entirely to the eligible patient. This offer is not health insurance and is only valid for patients in the 50 United States, Washington DC, Puerto Rico, Guam, and Virgin Islands. This offer is not valid for cash paying patients. This Program is void where prohibited by law. No membership fees. It is illegal to sell, purchase, trade, counterfeit, duplicate, or reproduce, or offer to sell, purchase, trade, counterfeit, duplicate, or reproduce the card. This offer will be accepted only at participating pharmacies. Certain rules and restrictions apply. Astellas reserves the right to revoke, rescind, or amend this offer without notice.

The Program has a maximum copay assistance limit of $7,000 per calendar year. After the annual maximum on copay assistance is reached, patient will be responsible for the remaining out-of-pocket costs for XTANDI. Astellas may reduce or discontinue the copay assistance available under the Program if it determines an enrolled patient is subject to a program offered by a third-party payer or pharmacy benefit manager, or an agent of either, that adjusts patients' out-of-pocket cost-sharing obligations based on the copay assistance provided by this Program, or excludes the copay assistance provided under this Program from counting towards an enrolled patient's out-of-pocket cost-sharing obligations (“maximizer” or “accumulator” program). The Program uses advanced logic to identify whether a claim for an enrolled patient is subject to a “maximizer” or “accumulator” program. Unless prohibited by law, Astellas may reduce the cost-sharing assistance available under the Program to a per claim maximum of $25 if it determines a claim for an enrolled patient is subject to a “maximizer” or “accumulator” program.

^†Subject to a maximum copay assistance limit of $7,000 per calendar year. Unless prohibited by law, Astellas may reduce the cost-sharing assistance available under the Program to a per claim maximum of $25 if it determines a claim for an enrolled patient is subject to a “maximizer” or “accumulator” program.

ASTELLAS PATIENT ASSISTANCE PROGRAM (PAP)*

Astellas PAP provides XTANDI at no cost to patients who meet the program eligibility requirements. Eligibility is determined on a patient-specific basis. XTANDI Support Solutions can quickly confirm whether your patient is eligible and answer any questions you may have.

Your patients may be eligible for this program if they:

Are uninsured; a patient is considered uninsured when a patient has no prescription drug insurance^†
Have a verifiable shipping address in the United States
Have been prescribed XTANDI for an FDA-approved indication
Meet the program financial eligibility requirements

*Subject to meeting eligibility requirements. Void where prohibited by law.

^†Other insured patients may be eligible for the program if they meet certain eligibility criteria.

XTANDI QUICK START+® PROGRAM

The XTANDI QUICK START+® Program provides a one-time, 14-day supply of XTANDI at no cost to new eligible patients who experience a delay in insurance coverage.

Patient eligibility requirements for this program include but are not limited to:

Have prescription drug insurance
Be new to XTANDI therapy
Have experienced an insurance-related access delay
Have been prescribed XTANDI for an FDA-approved indication

The program offers overnight shipping directly to the patient.

QUICK START+® is a registered trademark of Astellas US LLC.

INFORMATION ABOUT OTHER ASSISTANCE OPTIONS

XTANDI Support Solutions also offers information about other assistance options, such as Medicare Part D Extra Help.

Medicare Extra Help Patient Flashcard

Extra Help is a program to help eligible people pay Medicare Part D
prescription drug costs, including premiums, deductibles, and coinsurance.

View & Download (English) View & Download (Spanish)

XTANDI PATIENT CONNECT

XTANDI Patient Connect helps connect patients and their caregivers to independent resources and third-party support services that may help them manage their disease and daily life while on treatment. XTANDI Patient Connect resources offer emotional, logistical, and informational support.*

When a patient or caregiver calls XTANDI Support Solutions, a trained representative will assess their specific needs and will conduct a search of various independent local and national organizations* that may provide the support and resources requested.

The patient or caregiver will be able to contact those providers to enroll or engage in those services.

Resources provided by third-party organizations may include:

Emotional Support

Connecting patients to social workers, counseling services, or online communities
Emotional support for the caregiver

Logistical Support

Transportation and lodging assistance for treatment
Help with other day-to-day tasks

Informational Support

Education and resources
Advice and recommendations on nutrition and self-care

*Support is provided through third-party organizations that operate independently and are not controlled or endorsed by Astellas. Availability of support and eligibility requirements are determined by these organizations.

Provider Support

ELECTRONIC BENEFITS VERIFICATION

XTANDI Support Solutions can assist in the evaluation of a patient's insurance coverage for XTANDI. After performing a benefits verification, we will provide a Benefits Summary that includes:

The patient's insurance coverage requirements for XTANDI
Requirements for prior authorization, step edit, or other coverage restrictions, if any
Cost-sharing responsibility, including deductibles, coinsurance or copayment, and out-of-pocket maximums
A list of specialty pharmacies that participate in your patient's insurance coverage

Electronic Benefits Verification Process

Go to XTANDIaccess.com to enroll your patient in XTANDI Support Solutions.

Electronic Benefits Verification leverages a proprietary network of payers and pharmacy benefit managers to provide fast and comprehensive patient coverage results.

XTANDI Support Solutions will provide a detailed Benefits Summary that includes contact information for the in-network specialty pharmacy processing your patient's prescription.

PRIOR AUTHORIZATION ASSISTANCE

XTANDI Support Solutions can provide prior authorization (PA) assistance when a patient's insurer requires PA approval.

Prior Authorization Assistance Process

XTANDI Support Solutions will identify PA requirements, if any, and triage the patient's case to the network specialty pharmacy. The specialty pharmacy will initiate and support the PA.

XTANDI Support Solutions will follow up with the specialty pharmacy to track the patient's status and provide support as needed.

XTANDI Support Solutions will notify you of the outcome.

PRIOR AUTHORIZATION DENIAL APPEALS

If the patient's insurance denies a prior authorization (PA) request, XTANDI Support Solutions can assist the healthcare provider with an appeal for a denied PA request.

Prior Authorization Denial Appeal Process

We will determine if any additional documentation is required by the patient's insurer.

We will inform the HCP of what information is needed and how to provide it to the insurer.

We will track and inform the HCP of the appeal status.

HCP, healthcare provider.

1-800-727-7003
AstellasAnswers.com

Indications

XTANDI is indicated for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR), metastatic castration-sensitive prostate cancer (mCSPC), or castration-resistant prostate cancer (CRPC).¹

Important Safety Information

Important Safety Information and Indications

Warnings and Precautions

Seizure occurred in 0.6% of patients receiving XTANDI in eight randomized clinical trials. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Patients in the study had one or more of the following predisposing factors: use of medications that may lower the seizure threshold, history of traumatic brain or head injury, history of cerebrovascular accident or transient ischemic attack, and Alzheimer’s disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.

Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder that can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.

Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in eight randomized clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Permanently discontinue XTANDI for serious hypersensitivity reactions.

Ischemic Heart Disease In the combined data of five randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (3.5% vs 2%). Grade 3-4 ischemic events occurred in 1.8% of patients on XTANDI versus 1.1% on placebo. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart disease.

Falls and Fractures occurred in patients receiving XTANDI. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. In the combined data of five randomized, placebo-controlled clinical studies, falls occurred in 12% of patients treated with XTANDI compared to 6% of patients treated with placebo. Fractures occurred in 13% of patients treated with XTANDI and in 6% of patients treated with placebo.

Embryo-Fetal Toxicity The safety and efficacy of XTANDI have not been established in females. XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI and for 3 months after the last dose of XTANDI.

Dysphagia or Choking Severe dysphagia or choking, including events that could be life-threatening requiring medical intervention or fatal, can occur due to XTANDI product size. Advise patients to take each capsule or tablet whole with a sufficient amount of water to ensure that all medication is successfully swallowed. Consider use of a smaller tablet size of XTANDI in patients who have difficulty swallowing. Discontinue XTANDI for patients who cannot swallow capsules or tablets.

Adverse Reactions (ARs)

In the data from the five randomized placebo-controlled trials, the most common ARs (≥ 10%) that occurred more frequently (≥ 2% over placebo) in XTANDI-treated patients were musculoskeletal pain, fatigue, hot flush, constipation, decreased appetite, diarrhea, hypertension, hemorrhage, fall, fracture, and headache. In the bicalutamide-controlled study, the most common ARs (≥ 10%) reported in XTANDI-treated patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss.

In AFFIRM, the placebo-controlled study of metastatic CRPC (mCRPC) patients who previously received docetaxel, Grade 3 and higher ARs were reported among 47% of XTANDI-treated patients. Discontinuations due to ARs were reported for 16% of XTANDI-treated patients. In PREVAIL, the placebo-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to ARs were reported for 6% of XTANDI-treated patients. In TERRAIN, the bicalutamide-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 39% of XTANDI patients and 38% of bicalutamide patients. Discontinuations with an AR as the primary reason were reported for 8% of XTANDI patients and 6% of bicalutamide patients.

In PROSPER, the placebo-controlled study of nonmetastatic CRPC (nmCRPC) patients, Grade 3 or higher ARs were reported in 31% of XTANDI patients and 23% of placebo patients. Discontinuations with an AR as the primary reason were reported for 9% of XTANDI patients and 6% of placebo patients.

In ARCHES, the placebo-controlled study of metastatic CSPC (mCSPC) patients, Grade 3 or higher ARs were reported in 24% of XTANDI-treated patients. Permanent discontinuation due to ARs as the primary reason was reported in 5% of XTANDI patients and 4% of placebo patients.

In EMBARK, the placebo-controlled study of nonmetastatic CSPC (nmCSPC) with high-risk biochemical recurrence (BCR) patients, Grade 3 or higher adverse reactions during the total duration of treatment were reported in 46% of patients treated with XTANDI plus leuprolide, 50% of patients receiving XTANDI as a single agent, and 43% of patients receiving placebo plus leuprolide. Permanent treatment discontinuation due to adverse reactions during the total duration of treatment as the primary reason was reported in 21% of patients treated with XTANDI plus leuprolide, 18% of patients receiving XTANDI as a single agent, and 10% of patients receiving placebo plus leuprolide.

Lab Abnormalities: Lab abnormalities that occurred in ≥ 5% of patients, and more frequently (> 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are hemoglobin decrease, neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, hypophosphatemia, and hypercalcemia.

Hypertension: In the combined data from five randomized placebo-controlled clinical trials, hypertension was reported in 14.2% of XTANDI patients and 7.4% of placebo patients. Hypertension led to study discontinuation in < 1% of patients in each arm.

Drug Interactions

Effect of Other Drugs on XTANDI Avoid coadministration with strong CYP2C8 inhibitors. If coadministration cannot be avoided, reduce the dosage of XTANDI.

Avoid coadministration with strong CYP3A4 inducers. If coadministration cannot be avoided, increase the dosage of XTANDI.

Effect of XTANDI on Other Drugs Avoid coadministration with certain CYP3A4, CYP2C9, and CYP2C19 substrates for which minimal decrease in concentration may lead to therapeutic failure of the substrate. If coadministration cannot be avoided, increase the dosage of these substrates in accordance with their Prescribing Information. In cases where active metabolites are formed, there may be increased exposure to the active metabolites.

Indications

XTANDI (enzalutamide) is indicated for the treatment of patients with:

nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR)
metastatic castration-sensitive prostate cancer (mCSPC)
castration-resistant prostate cancer (CRPC)

Reference: 1. XTANDI. Package insert. Northbrook, IL: Astellas Pharma US, Inc; 2025.

XTANDI Support Solutions®